MedPath

Rhythmic Sensory Stimulation on Fibromyalgia

Not Applicable
Withdrawn
Conditions
Chronic Pain, Widespread
Registration Number
NCT06416826
Lead Sponsor
Women's College Hospital
Brief Summary

The aim of this project is to further examine the effectiveness of Rhythmic Sensory Stimulation (RSS) with low-frequency sounds and somatosensory stimulation as a complementary therapy for fibromyalgia, and to investigate potential mechanisms underlying the effects of RSS on chronic pain.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • patients with clinical diagnosis of fibromyalgia
  • able to read and write English adequately
  • have satisfactory hearing bilaterally (self-reported)
  • have the ability to operate the supplied device
Exclusion Criteria
  • acute and active inflammatory conditions (e.g., rheumatoid arthritis, osteoarthritis, autoimmune disease)
  • medical or psychiatric illness
  • history of psychosis, epilepsy, seizures
  • pregnancy or breast feeding
  • hemorrhaging or active bleeding
  • thrombosis, angina pectoris
  • heart disease, such as hypotension, arrhythmia, pacemaker
  • substance abuse (harmful or hazardous use of psychoactive subtances, including alcohol and illicit drugs) in the last year
  • suffering from a recently prolapsed vertebral disc
  • recovering from a recent accident with back or neck injury.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
change in inflammatory cytokine levelsbaseline, 1 month, 2 months

The investigator will use a multiplex enzyme-linked immunosorbent assay (ELISA) to asses inflammatory cytokines in fibromyalgia.

Secondary Outcome Measures
NameTimeMethod
change in EEG brain activitybaseline, 1 month, 2 months

The investigators will measure EEG dynamics to quantify dysfunctional activity in brain areas that are affected by fibromyalgia

change in pain severitybaseline, 1 month, 2 months

Patients will rate their pain severity on a scale from 0 (no pain) to 10 (extreme pain)

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